Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

IZO — Predicate Candidate Screening

163 FDA 510(k) clearances under this product code; the 50 most recent screened below.

60 daysmedian FDA review time

147 days90th percentile

163clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K954666	MPH50, MPH65, AND MPH80	GE Medical Systems	1995-11-24	45	0
K953582	HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPI	Varian Canada, Inc.	1995-09-26	56	0
K953831	N 800 HF	Nucletron-Oldelft Corp.	1995-09-08	24	0
K952822	SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G	Shimadzu Corp.	1995-07-12	22	0
K952265	MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/5	Control-X, Inc.	1995-07-06	52	0
K950883	POLYDOROS SX 65 AND 80	Siemens Medical Solutions USA, Inc.	1995-04-03	34	0
K950694	COMPACT-X	Electromed Intl., Ltd.	1995-03-31	45	0
K950291	DIGITAL 625HF	Fischer Imaging Corp.	1995-03-23	57	0
K945453	UD 150L-R II	Shimadzu Medical Systems	1995-03-21	134	0
K950040	SII 525 APR	Scott Imaging Intl., Inc.	1995-03-21	75	0
K950041	SII 360 APR	Scott Imaging Intl., Inc.	1995-03-21	75	0
K945452	UD 150L-F	Shimadzu Medical Systems	1995-03-21	134	0
K950037	N 800 HF	Oldelft Corp. of America	1995-02-15	42	0
K945731	HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS	Bennett X-Ray Corp.	1995-02-15	85	0
K945668	KXO-80G	Toshiba America Medical Systems, In.C	1994-12-27	40	0
K942731	SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR	Shimadzu Corp.	1994-10-13	147	0
K944149	MICRO X-80 HF	Fischer Imaging Corp.	1994-09-16	22	0
K944147	MICRO X-50 HF	Fischer Imaging Corp.	1994-09-16	22	0
K944148	MICRO X-30HF	Fischer Imaging Corp.	1994-09-16	22	0
K944150	MICRO X-65 HF	Fischer Imaging Corp.	1994-09-16	22	0
K943652	VASCULAR MP X-RAY GENERATOR	GE Medical Systems	1994-08-22	25	0
K943504	RSX-525HF	Fischer Imaging Corp.	1994-08-17	28	0
K942778	MODEL VPW2877F8, MAMMO 5 POWER SUPPLY	Varian Assoc., Inc.	1994-07-29	46	0
K942100	MODEL TM EP HIGH VOLTAGE GENERATOR	Continental X-Ray Corp.	1994-06-07	42	0
K934686	MOLYBDENUM/RHODIUM FILTERS	Continental X-Ray Corp.	1994-05-26	239	0
K940227	SCPU X-RAY GENERATOR	General Electric Co.	1994-04-28	100	0
K934967	SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR	Shimadzu Corp.	1993-12-13	59	0
K933777	CONCEPT ONE	Innerscan, Inc.	1993-12-13	132	0
K935068	RADIOGRAPHIC GENERATOR HFQ-WHIS	Bennett X-Ray Corp.	1993-12-13	49	0
K933471	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G	Shimadzu Corp.	1993-11-24	132	0
K933650	PHILIPS XRG 90 X-RAY GENERATOR SYSTEM	Philips Medical Systems North America, Inc.	1993-10-07	72	0
K933240	POLYDOROS IS	Siemens Medical Solutions USA, Inc.	1993-09-07	67	0
K931930	POYDOROS LX	Siemens Medical Solutions USA, Inc.	1993-09-07	144	0
K931998	LCR GENERATOR	Philips Medical Systems (Cleveland), Inc.	1993-07-27	95	0
K930792	RSX 30HF	Fischer Imaging Corp.	1993-05-19	92	0
K931049	ADVANTX SYSTEM	GE Medical Systems	1993-05-19	79	1
K926365	MAGMA XHF-30, XHF-40, XHF-50	Imaging and X-Ray Intl., Inc.	1993-03-26	94	0
K920349	PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR	Control-X, Inc.	1993-02-12	385	0
K920351	PCX 650HF RADIOGRAPHIC X-RAY	Control-X, Inc.	1993-02-12	385	0
K925684	OLYMP-X,X-RAY GENERATOR	Afp Imaging Corp.	1993-02-02	82	0
K924078	POLYDOROS C	Siemens Medical Solutions USA, Inc.	1993-01-26	167	0
K925844	PHILIPS SUPER CP FAMILY	Philips Medical Systems, Inc.	1992-12-28	40	0
K925105	PHILIPS MEDIO CP FAMILY	Philips Medical Systems, Inc.	1992-12-28	81	0
K923786	POLYDOROS XS50 AND SX80	Siemens Medical Solutions USA, Inc.	1992-12-17	142	0
K921875	X-RAY CONTROL AND HI-VOLTAGE GENERATOR	Continental X-Ray Corp.	1992-10-15	178	0
K922814	TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT	Bay Shore Medical Equipment Corp.	1992-09-11	101	0
K922165	ATC725, ATC525, AND AP300	Gendex Corp.	1992-07-27	80	0
K921951	MPG 65-80-100 X-RAY GENERATOR AND CONTROL	General Electric Co.	1992-07-21	85	0
K921516	P2900 X-RAY GENERATOR	Precise Optics Photo Medic Equipment, Inc.	1992-05-28	58	0
K920730	X-RAY HIGH VOLTAGE GENERATOR ED 125L	Shimadzu Medical Systems	1992-04-27	69	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda